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Friday, July 16, 2010

EXecutive/ Assistant Manager Regulatory Affairs (Local market)

Summary

Experience:
2 - 5 Years
Location:
Gurgaon
Compensation:
Rupees 4,75,000 - 7,00,000
Education:
UG - Any Graduate - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Bio-Chemistry, Chemistry,M.Tech - Bio-Chemistry/Bio-Technology
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

2 - 5 years of experience regulatory affairs, dealing with Central and State Drug Control Authorities for Drugs, Pharmaceutical Formulations, Medical Devices etc.



Competencies:



• Thorough knowledge of FDA regulations, D&C act and Rules and regulatory guidelines.

• Knowledge of DCGI regulatory processes for Drugs and Medical Devices, WHO-GMP certification/ Schedule M;

• Excellent verbal and written communication skills,

• Strong interpersonal skills.

• Highly committed and resourceful.

• Well developed presentation skills.

 

Job Description

Key Responsibility: Ensuring business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.



Primary Tasks:

• Submission and tracking of registration applications for Import of New Products in India,

• Submission and tracking of re-registration applications for products in India,

• Liaisoning with the source company and obtaining all the relevant details for filing any change to the approved products/licences.

• Assess all the Enterprise Change Orders/ Change controls from all the franchises from regulatory perspective and continuously ensure regulatory compliance.

• Strenthening of the Quality system procedures speed to market for the new products.



Secondary Tasks:

• Compilation and dispatch of registration applications in AP export markets,

• Re-registration of products in AP export markets for Ex- India manufacturing sites,



Contacts:



Internal: QA, Operations/ manufacturing, R&D, Sales and Marketing, Product management, Purchase, Warehouse(s), International Business, Professional Education, Supply chain and imports, Regional planning, Source companies, Legal dept, etc.



External: Central and State Regulatory authorities, Procurement bodies, Tendering authorities, Dealers and distributors, Affiliate country contacts, etc

 
Keywords: DCGI, D&C Acts, Regulatory Affairs, regulatory authority

Company Profile

The client is a Fortune 100 company with global presence in pharmaceutical and medical devices. The client is known for its corporate reputation and is ranked one of the world’s most respected companies. The client has operations in more that 50 countries and their products are sold in more than 170 countries.

Elixir, a leading Recruitment Process Outsourcing offers end-to-end recruitment solutions to meet customer needs throughout the recruitment cycle. The company specializes in RPO, Executive search, Contingent hiring, On-site consulting, Assessments, Organizational consulting, HR outsourcing and contract recruitment. By offering a complete range of services, the product portfolio assists customers to raise productivity through improved strategy, quality, efficiency and cost reduction. A high performance, people solutions company with strong presence across industries and levels, Elixir clientele spans high profile early stage to large Fortune 1000 companies.
Contact Details
Company Name:
A Fortune 100 healthcare client of Elixir
Executive Name:
Tanu Singh
Address:
D- 6 Sector 10
NOIDA,Uttar Pradesh,India 201301
Email Address:
Telephone:
91-120-4510986

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